FDA Clears Tongue Stimulator You Use During the Day to Reduce Snoring and Sleep Apnea – Gizmodo

There aren’t many options currently available on the market to help people who snore relieve their suffering, or the suffering of anyone stuck within earshot. But a new gadget approved by the U.S. Food and Drug Administration on Friday could be a game changer for those bedtime woes, and the best part is it you don’t even have to wear it at night.

The eXciteOSA device is the first of its kind cleared to treat snoring and mild obstructive sleep apnea, a condition that involves a person’s airway routinely getting blocked while they sleep, by stimulating a person’s tongue muscle. While many other snoring and sleep apnea treatments target the nose and aim to keep the nostril’s airways clear, the tongue is just as much of a culprit behind the problem, as it can collapse backward while a person sleeps and block airflow.

To try to keep this from happening, the eXciteOSA mouthpiece uses four electrodes—two above the tongue and two below—to deliver neuromuscular stimulation through a series of electrical pulses with rest periods in between. Patients use the device on their tongue for 20 minutes a day over the course of a six-week period to start, then once per week after that.

On Friday, the FDA granted marketing authorization to Signifier Medical Technologies, the device’s developer. The agency said the device reduced loud snoring (anything over 40dB) by 20% in 87 out of the 155 patients involved in its assessment, per a press release. Out of a subset of patients who struggled with both snoring and mild sleep apnea, the device reduced each person’s Apnea-Hypopnea Index, which measures the severity of obstructive sleep apnea, by an average of 48% in 41 out of 48 patients. As for side effects, the most common the FDA observed were excessive salivation, tongue or tooth discomfort, tongue-tingling, dental filling sensitivity, metallic taste, gagging, and tightness in the jaw.

The eXciteOSA mouthpiece is prescription-only for now and is meant for adults 18 and up who don’t have contraindicated issues or devices, which include pacemakers, implanted pacing leads, temporary or permanent implants, dental braces, and dental jewelry, among others. It’s also not intended to treat severe obstructive sleep apnea, and patients should get a comprehensive dental examination prior to starting treatment, per the agency.

Obstructive sleep apnea is a prevalent sleep disorder that can potentially lead to serious medical conditions if left untreated, such as glaucoma, diabetes, heart conditions, cancer, and cognitive and behavioral disorders, the FDA said. One study by the U.S. Department of Health and Human Services found that an estimated 936 million adults between the ages of 30 and 69 experience mild to severe obstructive sleep apnea worldwide.

“Obstructive sleep apnea not only impacts sleep quality, but can have other serious health impacts if untreated. Today’s authorization offers a new option for the thousands of individuals who experience snoring or mild sleep apnea,” said Dr. Malvina Eydelman, director of the Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices in the FDA’s Center for Devices and Radiological Health, in the agency’s press release.

While snoring can undoubtedly be annoying for those forced to listen to that racket throughout the night (totally not speaking from experience here…), it’s not necessarily indicative of a more serious sleep disorder, though many of its symptoms overlap with obstructive sleep apnea. It is a common issue, though: Roughly 45% of adults snore occasionally, while a quarter of all adults snore regularly according to John Hopkins researchers.

The eXciteOSA mouthpiece obviously isn’t the holy grail cure to these issues, but it has shown some promising results so far and could inspire future treatments that try new methods of nipping these sleeping conditions in the bud. And I’m sure anyone who deals with a snoring partner will agree that any solution that leads to more Zzzs and fewer earplugs is a good one.

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